RecruitingPhase 4NCT07474519

Studying the Relationship of Patient Positioning and Intravesical Bacillus Calmette Guerin Dwell Time to Improve the Treatment of Non-muscle Invasive Bladder Cancer

An Assessment of Patient Position and Intravesical BCG Dwell Time


Sponsor

Ohio State University Comprehensive Cancer Center

Enrollment

40 participants

Start Date

Feb 26, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This phase IV trial studies whether there is a relationship between how a patient is positioned while receiving bacillus Calmette Guerin (BCG) within the bladder (intravesical) and how long BCG stays in the bladder (dwell time) to improve the treatment of non-muscle invasive bladder cancer. For the past 40 years, intravesical BCG has been used for the treatment of non-muscle invasive bladder cancer. An important factor for BCG treatment is the dwell time, which is the period of time a patient can hold the BCG medication in the bladder after it has been given. Normally, patients are instructed during intravesical BCG treatment to avoid emptying the bladder for 2 hours after the BCG is given. However, this may be difficult for some patients who may have limited bladder capacity, restricted movement, or severe urinary symptoms. There have been studies outlining the relationship with increased dwell time and how well the treatment works, but studies on the potential impact of patient positioning or activity on the patient's ability to retain the drug are limited. Researchers hope by studying whether there is a relationship between patient positioning during intravesical BCG treatment and dwell time, they may be able to improve how BCG treatment for non-muscle invasive bladder cancer is given, especially for patients with limited bladder capacity, restricted movement, or severe urinary symptoms.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • Patient with intermediate or high risk NMIBC opting for intravesical induction BCG
  • Has not initiated induction therapy
  • Able to remain in supine position for two hours. (Head may be raised on up to two pillows)
  • Able to remain in a sitting position for two hours
  • Willingness to utilize a wearable fitness tracker for at least five days during the study
  • Able to perform a remote video or telephone encounter
  • Able to provide informed consent

Exclusion Criteria4

  • Receipt of intravesical BCG within the past 1 year
  • Known inability to retain BCG
  • History of urinary incontinence with a score of 3 or more on the Overactive Bladder Survey (OAB) urgency, urgency incontinence, or incontinence questions
  • Refusal to wear a fitness tracker during a 24-hour baseline, during treatment, and/or for 2 hours post treatment

Interventions

PROCEDUREAccelerometry

Receive and wear Fitbit

BIOLOGICALBCG Solution

Given intravesically with no activity restrictions

BIOLOGICALBCG Solution

Given intravesically in lying down position

BIOLOGICALBCG Solution

Given intravesically in sitting position

OTHERElectronic Health Record Review

Ancillary studies

BEHAVIORALPatient Discharge

Receive immediate clinic discharge

OTHERSurvey Administration

Ancillary studies


Locations(1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

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NCT07474519


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